Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies

NCT06787482 | Recruiting Phase 1

• 1 other identifier: ACE_Retino_EG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Summary of the Study This clinical trial evaluates a novel peptide-based therapy for treating retinal dystrophies, age-related macular degeneration (AMD), and diabetic retinopathy (DR). The therapy consists of peptides derived from fetal tissues, mesenchymal stem cells (MSCs), and bioactive growth factors, administered sublingually for systemic absorption. Study Objectives: Primary Objectives: Assess safety and tolerability, and evaluate the therapy's effects on retinal function and structure. Secondary Objectives: Explore improvements in visual acuity, retinal thickness, vascular health, and disease biomarkers. Study Design: Type: Open-label, single-arm interventional study. Duration: 12 months. Participants: 150 adults, divided into three cohorts: Retinal dystrophies. AMD (dry and wet forms). DR (moderate NPDR and PDR). Intervention: A sublingual solution containing peptides and growth factors, taken 4 times daily. Outcome Measures: Primary Outcomes: Safety (adverse events) and tolerability (treatment adherence). Secondary Outcomes: Functional: Visual acuity and field sensitivity improvements. Structural: Retinal thickness and vascular health. Biomarkers: Serum VEGF, oxidative stress, and inflammatory markers. Study Procedures: Monthly follow-ups for safety monitoring, vision tests, retinal imaging (OCT, FA), and blood biomarker analysis. Comprehensive evaluations at baseline, 6 months, and 12 months. Significance: The study aims to provide an innovative, non-invasive treatment for debilitating retinal conditions, potentially improving vision and retinal health through systemic therapy.

Conditions

Retinitis Pigmentosa (RP); Age Related Macular Degeneration; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• change in BVCA

  change in BCVA (best-corrected visual acuity). The calculation is based on detecting a clinically meaningful improvement in BCVA using a paired design (before and after treatment within the same subjects).

  3 months

Secondary Outcomes (1)

• change in OCT

  3 months

Study Arms (2)

administer 1 ml of Ace Retino 4 times daily for 6 months,safety evaluation

ACTIVE COMPARATOR

Primary Objective: Evaluate the safety and tolerability of ACE Retino in individuals with RP.

Dietary Supplement: ACE Retino

test efficacy for ACE Retino 1 ml 4times daily sublingual for 6 months

EXPERIMENTAL

Assess the efficacy of ACE Retino in improving retinal structure and function. Explore the potential for photoreceptor and retinal pigment epithelial (RPE) regeneration.

Dietary Supplement: ACE Retino

Interventions

ACE Retino DIETARY_SUPPLEMENT

1 ml sublingually self administer / 4 times/day for 6 months

administer 1 ml of Ace Retino 4 times daily for 6 months,safety evaluation; test efficacy for ACE Retino 1 ml 4times daily sublingual for 6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years with a confirmed genetic or clinical diagnosis of RP.
• Visual acuity of ≥1/60 in at least one eye.
• Stable ocular and systemic condition over the past six months.
• Ability to provide written informed consent

You may not qualify if:

• Significant ocular comorbidities (e.g., advanced glaucoma, diabetic retinopathy).
• Recent ocular surgery (within six months) or current use of investigational drugs.
• Systemic conditions affecting study outcomes (e.g., uncontrolled diabetes, autoimmune diseases).
• Pregnancy or lactation.

Sponsors & Collaborators

• Ace Cells Lab Limited: lead
• European Wellness Academy: collaborator

Study Sites (2)

Dr. Seif Clinic

Cairo, Egypt

RECRUITING

British Center for Regeerative medicne (Cairo)

Giza, !2112, Egypt

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Retinitis Pigmentosa; Macular Degeneration; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Dr. Passant Sayed Saif, PhD ophthalmology

  Associate prof of Ophthalmology Misr University for science and technology

  PRINCIPAL INVESTIGATOR

• Dr. Mohammed Yasser Sayed Saif, PhD Ophthalmology

  Dean of NILES Prof of Ophthalmology Beni-Suef University

  PRINCIPAL INVESTIGATOR

• Dr. Alaa Abdelkarim Mohammed, MRCPUK Endocirnology

  ACE Cells Lab Limited Chief Medical Consultant

  PRINCIPAL INVESTIGATOR

• Dr. Ahmed Tamer Sayed Saif, PhD Ophthalmology

  Chairman of Ophthalmology department Associate prof of Ophthalmology Fayoum university

  PRINCIPAL INVESTIGATOR

• DR. Mike Chan, stem cells expert

  European Wellness Academy

  STUDY CHAIR

Central Study Contacts

Dr. Alaa Abdelkairm Mohammed, MRCPUK Endocrinology

CONTACT

+447473922553; dralaakarim@gmail.com

Dr. Shireen Amer, M.Sc Occupational&industrial M

CONTACT

+20 100 069 9555; Shireenamer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study should enroll 25 participants, rounded to 30 participants to ensure adequate power after accounting for variability and potential dropouts

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: November 12, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-01

Locations

EG (2)